Percent of Patients Achieving Stable Disease (SD) [ Time Frame: During the first 4 months ] [ Designated as safety issue: No ]

Neither sufficient shrinkage to qualify for Partial Response nor sufficient increase to qualify for Progression Disease, taking as reference the smallest sum of the longest diameter since the treatment started.

Percent of Patients Achieving Partial Response (PR) [ Time Frame: during the first 4 months ] [ Designated as safety issue: No ]

The primary efficacy variable was defined as the proportion of patients with a best overall response of CR by Week 16/Month 4 based on local assessment according to RECIST (Version 1.0). This is an at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.

Percent of Patients Achieving Complete Response (CR) [ Time Frame: during the first 4 months ] [ Designated as safety issue: No ]

Complete response (CR) is the Disappearance of all target lesions.

Secondary Outcome Measures:

Analysis of Time to Overall Response (CR or PR) According to RECIST Using Kaplan-Meier Method for ITT Population [ Time Frame: 24 weeks and 52 weeks ] [ Designated as safety issue: No ]

Complete Response (CR): Disappearance of all target lesions. and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.

Time to Overall Response (CR or PR): Per Protocol Population [ Time Frame: 24 weeks and 52 weeks ] [ Designated as safety issue: No ]

Complete Response (CR): Disappearance of all target lesions, and Partial Response (PR): At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.

Time to Tumor Progression [ Time Frame: during the first 4 months ] [ Designated as safety issue: No ]

Time to tumor progression defined as the time from start of treatment to observed tumor progression (censoring for death without progression) as stated in the original protocol was not evaluated as stated in section 9.8.3 of the clinical study report.

The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence

Overall Survival, Number of Events Related to Progression of the Disease [ Time Frame: during 12 months ] [ Designated as safety issue: No ]

The OS rate could not be calculated due to the high number of censored cases. Number of censored, n (%) 108 (86.4). Only available data is number of events. OS was defined as the time from first study drug administration to death from any cause. If a patient was not known to have died, survival was censored at date of last contact.

Progression Free Survival (PFS) of the Patients Who Were Included Due to an Intolerability of a Prior Treatment. [ Time Frame: during 12 months ] [ Designated as safety issue: No ]

Progression-free survival (PFS) is defined as the time from first study drug administration to objective tumor progression or death from any cause. If a patient has not had an event, PFS is censored at the date of last adequate tumor assessment.

Prior or concomitant malignancies requiring active treatment other than GIST with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ.

Impaired cardiac function at visit 1

Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. impairment of gastrointestinal (GI) function, or GI disease that may significantly alter the absorption of the study drugs, uncontrolled diabetes.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289028